Phase II Study of Rituximab and Gemcitabine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Hoosier Oncology Group LYM03-64
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 9
- 主要终点
- · Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
研究概览
简要总结
Rituximab has been demonstrated to sensitize drug-resistant NHL cells to the cytotoxic actions of several chemotherapy agents by enhancing sensitivity of tumor cells to chemotherapy-induced apoptosis. Gemcitabine, a nucleoside analog that is used in several other malignancies, has shown very promising activity in patients with refractory Hodgkin's disease and low-grade NHL. The combination of rituximab and gemcitabine may have synergistic cytotoxic action in patients with relapsed or refractory DLBCL and possibly lead to improved response rates and demonstrable clinical benefit.
This trial will investigate the efficacy the combination of rituximab and gemcitabine in treating patients with relapsed or refractory DLBCL.
详细描述
OUTLINE: This is a multi-center study.
- Rituximab 375 mg/m2 day 1 of 21 day cycle
- Gemcitabine 1000 mg/m2 days 1 and 8 of 21 day cycle
Subgroup 1. Relapsed after responding to first line chemotherapy, who are not candidates for salvage high-dose chemotherapy.
Subgroup 2. Failure to achieve a complete response or relapsed after responding to salvage chemotherapy (any number of salvage regimens allowed), who are not candidates for high-dose chemotherapy.
Subgroup 3. Refractory to first line chemotherapy and/or 1 (one) salvage chemotherapy regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven DLBCL which meet the criteria of any of the 4 subgroups
- •Transformed DLBCL from a previous indolent NHL which meet the criteria of any of the 4 subgroups and have received at least one standard chemotherapy regimen for aggressive NHL or a biopsy upon progression of disease has been obtained to confirm the presence of DLBCL. The concomitant presence of a component of low grade lymphoma will NOT exclude participation
- •Measurable disease per Standardized Response Criteria for Non-Hodgkin's Lymphoma
- •Prior gemcitabine therapy is allowed.
- •Negative pregnancy test
排除标准
- •No history of life-threatening reactions to rituximab.
- •No history of gemcitabine intolerance; prior gemcitabine therapy is allowed.
- •No history of malignancy in the last 5 years (basal cell carcinoma of the skin excluded).
- •No central nervous system or cerebrospinal fluid involvement
- •No other investigational drugs received within 30 days prior to being registered for protocol therapy.
- •No active infections.
- •No current breastfeeding
研究组 & 干预措施
1
Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
干预措施: Rituximab (Drug)
1
Rituximab + Gemcitabine for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
干预措施: Gemcitabine (Drug)
结局指标
主要结局
· Evaluate response rates to the rituximab plus gemcitabine treatment combination in patients with relapsed or refractory DLBCL.
时间窗: 18 months
次要结局
- · Evaluate toxicity, time to progression and overall survival.(18 months)